convalescent plasma trial in covid -19 patients

Conditions: SARS-CoV 2; COVID-19

Summary: plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, ebola virus infection and in h1n1 influenza. more recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated covid-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. however, this was not a clinical trial and the patients were on other antiviral medication.; therefore, there is a need to undertake such a trial to see if deploying plasma with sars-cov-2 neutralizing antibody has utility in managing patients infected with covid-19 in respiratory distress. the objective of this pilot study is to compare plasma therapy using convalescent plasma with antibody against sars-cov-2 to usual supportive therapy in covid-19 patients with pneumonia and hypoxia, and to determine if the clinical course is improved. the difference between groups will allow an effect size to be determined for a definitive clinical trial.

coronavirus disease 2019 (covid-19) is caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) and has developed into a pandemic with serious global public health and economic sequelae. as of march 30, 2020, over 750,000 cases have been confirmed worldwide leading to over 34,000 deaths (https://coronavirus.jhu.edu/map.html). there is no current vaccine available, but there have been a number of reports of medication such as hydroxychloroquine having antiviral properties with efficacy against sars-cov-2. plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, ebola virus infection and in h1n1 influenza. more recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated covid-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. however, this was not a clinical trial and the patients were on other antiviral medication; therefore, there is a need to undertake such a trial to see if deploying plasma with sars-cov-2 neutralizing antibody has utility in managing patients infected with covid-19 in respiratory distress. the objective of this pilot study is to compare plasma therapy using convalescent plasma with antibody against sars-cov-2 to usual supportive therapy in covid-19 patients with pneumonia and hypoxia, and to determine if the clinical course is improved. the difference between groups will allow an effect size to be determined for a definitive clinical trial could using convalescent plasma transfusion, from recovered covid19 patients with antibody against covid-19 be beneficial in treatment of covid19 patients with hypoxia and pneumonia, in order to avoid or delay the need for invasive ventilation? this is a prospective, interventional and randomized open label trial involving 40 patients with covid-19 who are in respiratory distress, with the criteria that all require oxygen therapy and have radiological evidence of pneumonia, 20 of whom will receive a single transfusion of convalescent patient plasma plus routine care, compared to 20 covid-19 patients who will receive routine care alone.

Eligibility criteria:
inclusion criteria: * covid-19 diagnosis * hypoxia, (oxygen saturation of less than or equal 92% or po2 \< 60mmhg on arterial blood gas analysis) and patient requiring oxygen therapy * evidence of infiltrates on chest xray or ct scan * able to give informed consent * patients between the ages of 21 and above with no upper age. exclusion criteria: * patients with mild disease not requiring oxygen therapy * patients with normal cxr \& ct scan * patients requiring ventilatory support * patients with a history of allergy to plasma, sodium citrate or methylene blue * patients with a history of autoimmune disease or selective iga deficiency.

Keywords: plasma therapy covid-19